Mast Assure
Escherichia coli Monovalent O Antiserum - Factor O157 - 2ml
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Jilin.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
Record
| Listed by | Mast Group Ltd., United Kingdom |
|---|---|
| FDA product code | GNA |
| Device type | Antisera, All Types, Escherichia Coli |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3255 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-25 |
| Record revised | 2018-09-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M12030 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mast Assure Antisera | Mast Group Ltd. | 7 |
| E. coli O134 serum high titer, 1 mL | SSI Diagnostica A/S | 2 |
| Prolex E. coli O111 Latex Reagent | pro-lab incorporated | 1 |
| E. coli O73 serum high titer, 1 mL | SSI Diagnostica A/S | 1 |
| E. coli O25 serum, 1 mL | SSI Diagnostica A/S | 1 |
| E. coli O89 serum high titer, 1 mL | SSI Diagnostica A/S | 1 |
| ImmuLex E. coli O55, 1.5 mL | SSI Diagnostica A/S | 1 |
| E. coli O60 serum, 1 mL | SSI Diagnostica A/S | 1 |
| E. coli O10 serum high titer, 1 mL | SSI Diagnostica A/S | 1 |
| E. coli O110 serum, 1 mL | SSI Diagnostica A/S | 1 |
| E. coli O88 serum high titer, 1 mL | SSI Diagnostica A/S | 1 |
| E. coli O147 serum, 1 mL | SSI Diagnostica A/S | 1 |
Showing 12 of 492. All products under Antisera, All Types, Escherichia Coli
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.